CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 68071-3462
- 11-digit product format
- 680713462
- Labeler code
- 68071
- Product ID
- 68071-3462_14a7402c-8406-3acb-e063-6394a90a6b7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2017-05-31
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CYCLOBENZAPRINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3462-2 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 68071-3462-3 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 68071-3462-5 | CYCLOBENZAPRINE HYDROCHLORIDE | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3462 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 3 package rows | 20240328_00dbe051-a392-e2c6-e063-6394a90ab7f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3462-2 | 68071346202 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3462-2) | 2023-07-19 | No | No | Current |
| 68071-3462-3 | 68071346203 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3462-3) | 2023-07-31 | No | No | Current |
| 68071-3462-5 | 68071346205 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3462-5) | 2023-07-19 | No | No | Current |